54868-1037 : Asa 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule


NDC54868-1037
Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name: Butalbital, Aspirin, Caffeine and Codeine Phosphate
Dosage Form: Oral Capsule
Application #: ANDA074359
Rev. Date: 
CSA Schedule: CIII (US) [1]


[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: WATSON;3546
Shapes:  Capsule
Colors:  Blue / Yellow
Size (mm): 22
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

WATSON 3546: (0591-3546) Asa 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Physicians Total Care, Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 54868-1037-1: 20 CAPSULE IN 1 BOTTLE (54868‑1037‑1)
  • 54868-1037-3: 30 CAPSULE IN 1 BOTTLE (54868‑1037‑3)
  • 54868-1037-4: 120 CAPSULE IN 1 BOTTLE (54868‑1037‑4)
  • 54868-1037-5: 60 CAPSULE IN 1 BOTTLE (54868‑1037‑5)

Active Ingredients:

  • Aspirin
  • Butalbital
  • Caffeine
  • Codeine Phosphate

Dosage Strength:

  • 325 mg
  • 50 mg
  • 40 mg
  • 30 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Starch, Corn
  • Talc
  • D&c Yellow No. 10
  • Fd&c Blue No. 1
  • Fd&c Red No. 3
  • Fd&c Yellow No. 6
  • Gelatin
  • Titanium Dioxide
  • Ferric Oxide Red

Pharmaceutical Classes:

  • Barbiturate [EPC]
  • Barbiturates [Chemical/Ingredient]
  • Cyclooxygenase Inhibitors [MoA]
  • Decreased Prostaglandin Production [PE]
  • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Platelet Aggregation Inhibitor [EPC]
  • Decreased Platelet Aggregation [PE]
  • Central Nervous System Stimulant [EPC]
  • Central Nervous System Stimulation [PE]
  • Methylxanthine [EPC]
  • Xanthines [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 0527-1312 Asa 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Lannett Company, Inc.
  • 0591-3546 Asa 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Watson Laboratories, Inc.
  • 50090-0103 Butalbital, Aspirin, Caffeine and Codeine Phosphate Oral Capsule by A-s Medication Solutions LLC
  • 50564-507 Asa 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Jerome Stevens Pharmaceuticals
  • 54569-0337 Butalbital, Aspirin, Caffeine and Codeine Phosphate Oral Capsule by A-s Medication Solutions LLC
  • 63629-2952 Asa 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Bryant Ranch Prepack
  • 68308-312 Butalbital, Aspirin, Caffeine, and Codeine Phosphate Oral Capsule by Mayne Pharma Inc.
  • 69238-1993 Butalbital, Aspirin, Caffeine and Codeine Phosphate Oral Capsule by Amneal Pharmaceuticals LLC

NDC QR Code

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